Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment

Completed · Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study is to look at the safety and effectiveness of an experimental protease inhibitor (a type of anti-HIV drug) called BMS-232632. Doctors will compare an anti-HIV drug combination that includes BMS-232632 to a drug combination that includes ritonavir.

Key facts

Study ID

NCT00004584

Run by

Bristol-Myers Squibb

Starts

1999-12-01

Expected to finish

2002-01-01

Last updated by the study team

2011-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Are HIV-positive.
• Have a viral load (level of HIV in the blood) of at least 2,000 copies/ml.
• Have a CD4 count of at least 100 cells/mm3 (or at least 75 cells/mm3 in patients who have never had an AIDS-defining illness).
• Are currently receiving an anti-HIV drug combination that includes a protease inhibitor or nonnucleoside reverse transcriptase inhibitor (NNRTI), and they have been taking this drug combination for at least 24 weeks. They must have responded well to this treatment at first (their viral load decreased) but are currently experiencing an increase in viral load.
• Will most likely respond well to the study drugs, as shown by the results of a lab test.
• Are at least 18 years old.
• Agree to use effective barrier methods of birth control (such as condoms).
• Are available for follow-up for at least 48 weeks.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have a newly diagnosed opportunistic (HIV-related) infection requiring treatment.
• Have only recently become HIV positive.
• Abuse alcohol or drugs.
• Have severe diarrhea within 30 days of study entry.
• Have hemophilia.
• Have a history of pancreatitis.
• Have hepatitis within 30 days of study entry.
• Have peripheral neuropathy (a painful condition affecting the nervous system).
• Are unable to take medications by mouth.
• Are pregnant or breast-feeding.

Where it is running

• Sorra Research Ctr / Med Forum — Birmingham, Alabama, United States
• AIDS Healthcare Foundation — Los Angeles, California, United States
• Robert Scott MD — Oakland, California, United States
• Univ of California - Davis Med Ctr / CARES — Sacramento, California, United States
• Avalar Medical Group — Tarzana, California, United States
• Yale Univ School of Medicine / AIDS Program — New Haven, Connecticut, United States
• Community Research Initiative of South Florida — Coral Gables, Florida, United States
• HIV Clinical Research — Fort Lauderdale, Florida, United States
• Infectious Disease Research Institute — Tampa, Florida, United States
• Infectious Disease Specialists of Atlanta — Decatur, Georgia, United States
• Louisiana State Univ Med Ctr / HIV Outpatient Clinic — New Orleans, Louisiana, United States
• Albany Med College — Albany, New York, United States
• St Vincents Hosp / Clinical Research Program — New York, New York, United States
• Univ Hosps of Cleveland — Cleveland, Ohio, United States
• The Research and Education Group — Portland, Oregon, United States
• Julio Arroyo — West Columbia, South Carolina, United States
• Vanderbilt Univ Med Ctr — Nashville, Tennessee, United States
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Texas Tech Health Sciences Ctr — El Paso, Texas, United States
• Houston Clinical Research Network / Div of Montrose Clinic — Houston, Texas, United States
• Ottawa General Hospital — Ottawa, Ontario, Canada
• Toronto Hosp — Toronto, Ontario, Canada
• Montreal Chest Institute — Montreal, Quebec, Canada
• Hopital Pellegrin Tripode — Bordeaux, France
• Hopital De L'Hotel Dieu — Nantes, France

Full record on ClinicalTrials.gov

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